Manufacturing Engineer

Our client is a fast growing medical device manufacturer who is currently looking for an experienced Manufacturing Engineer to join their team in Mississauga.

This role will be responsible for the transfer of new products from engineering and assay development into manufacturing, designing, and developing assembly processes that assure the consistent and cost-effective production of high-quality, repeatable assemblies in prototypes through manufacturing scale-up and steady-state production in a cGMP environment.

Role and Responsibilities:

Execute the transfer of manufacturing processes and technologies from Research and Process Development groups into a cGMP environment.

Design the appropriate manufacturing processes, define and conduct process development activities, and provide design transfer inputs required as part of Tech Transfer.

As the manufacturing Subject Matter Expert, identify potential risks, evaluate impacts of manufacturing process steps and raw materials on product performance, and develop risk mitigations as part of the tech transfer and scale-up.

Interface with Engineering teams to define and establish manufacturing and inventory control processes for reagents, consumables, and instruments.

Support the Assay Development and Engineering teams to ensure the manufacture and supply of prototype consumable assemblies needed for assay design verification and clinical validation activities.

Establish appropriate manufacturing processes and controls to create and maintain consistency and quality of manufacturing from prototype through production scale-up.

Utilize your knowledge and experience to develop, assess, implement, and continually enhance cGMP manufacturing processes and operations.

Lead comprehensive validation activities including planning and execution of validation protocols for equipment, facilities, and processes.

Identification, procurement, installation, qualification (IQ, OQ, PQ), and maintenance of critical manufacturing equipment.

Create and maintain cGMP manufacturing documentation (e.g., Work Instructions, in-process, and final acceptance plans and records).

Support the creation and maintenance of Standard Operating Procedures (SOPs) for ISO13485 and cGMP processes.

Perform Root Cause Analysis of manufacturing failures, in collaboration with cross-functional team members, to determine failure causes, and define and implement improvements to address the causes of failures.

Drive Continuous Improvement in manufacturing by identifying improvement opportunities and developing and implementing process improvements.

Qualifications:

Bachelor’s degree in Engineering.

5+ years of manufacturing engineering and/or operational experience in similar industries combining biologicals and reagents with injection molded components.

Demonstrated critical thinking and analytical reasoning skills.

Ability to apply a disciplined engineering approach to define and execute designed experiments, analyze data as well as define problems, collect data, establish facts, and draw valid conclusions.

Familiarity with the manufacturing of reagents, consumables, instruments for IVDs, validation/qualification requirements, and cGMP processes.

Excellent communication skills and attention to detail.

Strong organizational skills and ability to multitask across projects and activities.